ทดสอบความสมบูรณ์ของบรรจุภัณฑ์โดยการวัดการสูญเสียสุญญากาศ – Vacuum Decay: Package Integrity Testing
การวัดการสูญเสียสุญญากาศเป็นวิธีการทดสอบความสมบูรณ์ของบรรจุภัณฑ์ที่มีประสิทธิภาพและเชื่อถือได้สูง ให้ข้อมูลเชิงปริมาณและผลลัพธ์ที่ชัดเจน แม้จะมีข้อจำกัดสำหรับวัสดุบางประเภท แต่ก็ยังคงเป็นเครื่องมือที่มีประโยชน์สำหรับการทดสอบบรรจุภัณฑ์หลายประเภท
Vacuum decay provides a quantitative physical measurement which allows for statistical analysis of data and a statistical approach to creating reject criteria. Packages tested with vacuum can be repeatedly tested with no detriment to the package itself. Repeated tests will provide the same result with every consecutive test. The vacuum decay test method not only provides numerical, quantitative data but allows the operator to see a definitive Pass or Fail result, eliminating any subjectivity or human interpretation. On rigid trays, vacuum decay allows for full container integrity testing with the exception of the porous lidding which needs to be covered or masked for testing. This masking of the Tyvek® lid must allow for detection of gross defects and micro defects between the tray flange and Tyvek®. Flange seals and the rigid tray can be reliably tested down to 100 microns with 100% accuracy as per ASTM F2338, but higher detectability can be achieved as per the example below. The below data set shows detection of leaks on a rigid tray covered with DuPont™ Tyvek® 1073B, with separation between the negative and positive controls over 4 standard deviations away from the negative control set. Positive controls were created at 50, 75, 100, and 125 microns. Certified 50-, 75-, and 125-micron controls were created by laser drilling, with the 100-micron controls with uncertified capillary tubes. Sustainable Deterministic Non-destructive Seal Integrity Testing for Life Sciences Packaging Although effective for a large variety of applications, vacuum decay does have some limitations. While the method excels with most non-porous applications and porous-lidded rigid trays, this pressure-based measurement system lacks the ability to test porous flexible substrates such as pouches. Contrary to porous-lidded rigid trays, porous flexibles allow gases to permeate through the substrate causing the headspace to be evacuated from the package before the test stage. Leaks in these materials are hidden within that natural leak rate and cannot be detected. Despite vacuum decay’s limitation on inspection of some porous packaging applications, the industry is not left without a deterministic test method.
#การวัดการสูญเสียสุญญากาศ #การทดสอบความสมบูรณ์ของบรรจุภัณฑ์ #ความแม่นยำ #ความน่าเชื่อถือ #ไม่ทำลาย #บรรจุภัณฑ์ #vacuumdecay #packageintegrity #testing #qualitycontrol #packaging #medicaldevices #pharmaceutical #healthcare #life #standards
